MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP ENTERALITE INFINITY ADMINISTRATION SET; ENTERAL INFUSION PUMP ACCESSORY

Model Number INF0500

Device Problem Free or Unrestricted Flow (2945)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/01/2015

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been returned to the manufacturer, so a proper evaluation of the cause of the reported administration set free flow event has not yet been possible.Moog will update this report with new information as it becomes available.

Event Description

Customer reported: "tonight, i had an incident with a malfunction in the feeding bag that could have caused severe harm to my patient.While i was changing out the feeding bag, i took the old feeding bag out of the pump (still attached to the patient) so i could prime the new feeding bag.When i disconnected the old feeding bag from my patient, i noticed that feeds were gushing out.The 40-50 mls of feed that were left in the old bag had rapidly free flowed into my (b)(6) patient (her feeds were currently at 20 ml/hr) in about 2 minutes time.I tried to aspirate off the tpt and only got 6 mls.I notified the [attending mds] of the incident.I stopped feeds x 1 hr per md order and abdominal girths have been started q shift." (b)(4).

• Brand Name: ENTERALITE INFINITY ADMINISTRATION SET
• Type of Device: ENTERAL INFUSION PUMP ACCESSORY
• Manufacturer (Section D): MOOG MEDICAL DEVICES GROUP; 4314 zevex park lane; salt lake city UT 84123
• Manufacturer (Section G): MOOG MEDICAL DEVICES GROUP; 4314 zevex park lane; salt lake city UT 84123
• Manufacturer Contact: matt brinkerhoff ; 4314 zevex park lane; salt lake city, UT 84123 ; 8012641001
• MDR Report Key: 5494323
• MDR Text Key: 40134071
• Report Number: 1722139-2016-00250
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031199
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: INF0500
• Device Catalogue Number: INF0500
• Device Lot Number: NOT PROVIDED
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 4